Prospective Sample Collection Study for Discovery and Evaluation of Novel Blood Based Biomarkers for Assessment of Hepatic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 575
- 试验地点
- 2
- 主要终点
- Identification of Advanced Fibrosis (≥F3)
研究概览
简要总结
Chronic liver disease (CLD) is a major cause of global mortality and morbidity . CLD patients are at an increased risk of developing liver fibrosis (formation of scar tissue), cirrhosis and liver failure and are at significant risk to develop primary liver cancer. Non-alcoholic fatty liver disease (NAFLD) represents a major risk for CLD and it is becoming the most common chronic liver condition with an estimated 25% global prevalence. Progression to non-alcoholic steatohepatitis (NASH) occurs in approx. 1 of 5 NAFLD patients and due to the rapidly rising etiology of end-stage liver disease, is currently the second most common etiology of hepatocellular carcinoma (HCC) requiring liver transplantation. Liver biopsy, currently the gold-standard for grading disease activity and staging fibrosis, is invasive, costly and at risk for sampling error. Due to the number of patients diagnosed with fibrosis and since fibrosis stage is prognostic of mortality and drives patient management, it is important to develop noninvasive yet accurate diagnostic tools that can identify fibrosis stage. The purpose of this study is to obtain a panel of clinically well characterized blood specimens to identify novel biomarkers to be used as an aid in diagnosis to assess the stage of clinically significant hepatic fibrosis in patients with signs or symptoms of NAFLD (NAFL/NASH). In addition, quantitative ultrasound (QUS) based approaches combined with artificial intelligence (AI) algorithms will be explored for assessing the stage of fibrosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for biopsy (or F0-F2 patients that underwent biopsy within the last 6 months but at least 1 month ago) suspected of having hepatic fibrosis due to NAFLD (NAFL/NASH) or patients with MASLD or MASH
- •Any FIB-4 value available
- •Any Fibroscan value available
- •Written and signed informed consent present
- •Patients aged ≥ 18 years to ≤ 75 years at the time of the blood draw
- •Body Mass Index (BMI) ≤ 45 kg/m²
排除标准
- •Vulnerable person: person deprived of liberty by a judicial or administrative decision and/or person under psychiatric care
- •Self-reported pregnancy or lactating females
- •Disease related to other etiologies, including alcoholic liver disease (alcoholic steatohepatitis), MetALD, specific etiology SLD (e.g. DILI or monogenic disease), cryptogenic SLD, viral hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis, human immunodeficiency virus, Wilson's disease, Hemochromatosis, alpha-1 antitrypsin deficiency
- •Any type of carcinoma, unless it is at least 5 years in remission
- •Prior liver transplant
- •Evidence of any other unstable or, untreated clinically significant immunological, neoplastic, endocrine, haematological, gastrointestinal, neurological or psychiatric disorder. Medically controlled comorbidities can be allowed
- •Self-reported alcohol consumption greater 30 g/day (males) 20 g/day (females)
- •Recent myocardial infarction (within last 6 months)
- •Inability to have a liver biopsy, or provide blood sample in a fasted status
- •F0-F2 recalled patients with +/- 5% change in weight between the biopsy and study inclusion
结局指标
主要结局
Identification of Advanced Fibrosis (≥F3)
时间窗: Through study completion, an average of 1 year.
he study aims to identify advanced liver fibrosis (stage F3 or higher) through various biomarkers. The assessment will determine the predictive value of these biomarkers for advanced stages of fibrosis (F3-F4)
Identification of Significant Fibrosis (≥F2)
时间窗: Through study completion, an average of 1 year.
The study aims to identify significant liver fibrosis (stage F2 or higher) through various biomarkers. This involves the comparison of biomarkers to biopsy results to determine their predictive value .
次要结局
- Performance of Biomarkers in Clinically Relevant Subpopulations(Through study completion, an average of 1 year.)
- Evaluation of Biomarker Panels(Through study completion, an average of 1 year.)